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High sensitivity and specificity rates of cobas® HPV test as a primary screening test for cervical intraepithelial lesions in a real-world setting

Cervical carcinoma (CC) is the fourth most common malignancy among women. Screening with Papanicolau smear is linked to a reduction in CC incidence rates when screening programs have been developed. However, this technique has several limitations, including moderate sensitivity rates for detection o...

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Autores principales: Fleider, Laura Alicia, de los Ángeles Tinnirello, María, Gómez Cherey, Facundo, García, María Gabriela, Cardinal, Lucía Helena, García Kamermann, Florencia, Tatti, Silvio Alejandro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9901754/
https://www.ncbi.nlm.nih.gov/pubmed/36745662
http://dx.doi.org/10.1371/journal.pone.0279728
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author Fleider, Laura Alicia
de los Ángeles Tinnirello, María
Gómez Cherey, Facundo
García, María Gabriela
Cardinal, Lucía Helena
García Kamermann, Florencia
Tatti, Silvio Alejandro
author_facet Fleider, Laura Alicia
de los Ángeles Tinnirello, María
Gómez Cherey, Facundo
García, María Gabriela
Cardinal, Lucía Helena
García Kamermann, Florencia
Tatti, Silvio Alejandro
author_sort Fleider, Laura Alicia
collection PubMed
description Cervical carcinoma (CC) is the fourth most common malignancy among women. Screening with Papanicolau smear is linked to a reduction in CC incidence rates when screening programs have been developed. However, this technique has several limitations, including moderate sensitivity rates for detection of cervical preneoplastic HPV-related lesions. In this real-world study, we proposed to evaluate the sensitivity and specificity rates of cobas® test, which amplifies target DNA fragments by polymerase chain reaction and hybridization of nucleic acids for the detection of 14 HR-HPV types in a single analysis) used as primary screening test for CC and preneoplastic lesions in women aged 25–65 years in a large University Hospital in Buenos Aires. A total of 1044 patients were included in the sample (median age: 46 years); sensitivity and specificity rates for the HR-HPV test used as primary screening test were 98.66% (95% confidence interval [95CI]: 97.67–99.3%) and 87.15% (95CI: 84.93–89.15%), respectively. The positive predictive value was 88.47% (95CI: 86.54%-90.42%) and the negative predictive value was 98.48% (95CI: 97.75%-99.23%). The cobas® HR-HPV testing was highly sensitive and specific for the detection of CC and preneoplastic lesions in real practice.
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spelling pubmed-99017542023-02-07 High sensitivity and specificity rates of cobas® HPV test as a primary screening test for cervical intraepithelial lesions in a real-world setting Fleider, Laura Alicia de los Ángeles Tinnirello, María Gómez Cherey, Facundo García, María Gabriela Cardinal, Lucía Helena García Kamermann, Florencia Tatti, Silvio Alejandro PLoS One Research Article Cervical carcinoma (CC) is the fourth most common malignancy among women. Screening with Papanicolau smear is linked to a reduction in CC incidence rates when screening programs have been developed. However, this technique has several limitations, including moderate sensitivity rates for detection of cervical preneoplastic HPV-related lesions. In this real-world study, we proposed to evaluate the sensitivity and specificity rates of cobas® test, which amplifies target DNA fragments by polymerase chain reaction and hybridization of nucleic acids for the detection of 14 HR-HPV types in a single analysis) used as primary screening test for CC and preneoplastic lesions in women aged 25–65 years in a large University Hospital in Buenos Aires. A total of 1044 patients were included in the sample (median age: 46 years); sensitivity and specificity rates for the HR-HPV test used as primary screening test were 98.66% (95% confidence interval [95CI]: 97.67–99.3%) and 87.15% (95CI: 84.93–89.15%), respectively. The positive predictive value was 88.47% (95CI: 86.54%-90.42%) and the negative predictive value was 98.48% (95CI: 97.75%-99.23%). The cobas® HR-HPV testing was highly sensitive and specific for the detection of CC and preneoplastic lesions in real practice. Public Library of Science 2023-02-06 /pmc/articles/PMC9901754/ /pubmed/36745662 http://dx.doi.org/10.1371/journal.pone.0279728 Text en © 2023 Fleider et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Fleider, Laura Alicia
de los Ángeles Tinnirello, María
Gómez Cherey, Facundo
García, María Gabriela
Cardinal, Lucía Helena
García Kamermann, Florencia
Tatti, Silvio Alejandro
High sensitivity and specificity rates of cobas® HPV test as a primary screening test for cervical intraepithelial lesions in a real-world setting
title High sensitivity and specificity rates of cobas® HPV test as a primary screening test for cervical intraepithelial lesions in a real-world setting
title_full High sensitivity and specificity rates of cobas® HPV test as a primary screening test for cervical intraepithelial lesions in a real-world setting
title_fullStr High sensitivity and specificity rates of cobas® HPV test as a primary screening test for cervical intraepithelial lesions in a real-world setting
title_full_unstemmed High sensitivity and specificity rates of cobas® HPV test as a primary screening test for cervical intraepithelial lesions in a real-world setting
title_short High sensitivity and specificity rates of cobas® HPV test as a primary screening test for cervical intraepithelial lesions in a real-world setting
title_sort high sensitivity and specificity rates of cobas® hpv test as a primary screening test for cervical intraepithelial lesions in a real-world setting
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9901754/
https://www.ncbi.nlm.nih.gov/pubmed/36745662
http://dx.doi.org/10.1371/journal.pone.0279728
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